Otsuka and Lundbeck's Once-Monthly Abilify Maintena® (Aripiprazole) Now Approved in Europe for Maintenance Treatment of

Otsuka and Lundbeck's Once-Monthly Abilify Maintena® (Aripiprazole) Now
Approved in Europe for Maintenance Treatment of Schizophrenia in Adult
Patients Stabilized with Oral Aripiprazole
*Preventing relapse is critical in the treatment of schizophrenia. Pivotal
studies, that supported the EU submission, demonstrate that Abilify
Maintena can reduce the risk of relapse relative to placebo and is
non-inferior to oral aripiprazole in patients with schizophrenia^1,2
*The approval of Abilify Maintena now provides patients with schizophrenia
access to a once-monthly formulation with established efficacy together
with a tolerability profile that is comparable to that of oral ABILIFY®
(aripiprazole)^2
*At the end of the randomized, double-blind treatment phase in one of the
pivotal trials, 93 percent of patients reported being extremely, very or
somewhat satisfied with Abilify Maintena treatment^3
*Abilify Maintena is the only dopamine D2 partial agonist in a
once-monthly, injectable form to receive marketing authorization in Europe
for maintenance treatment of schizophrenia
*Abilify Maintena will be the first commercialized product in Europe from
the global alliance between Otsuka and Lundbeck which is focused on
developing Central Nervous System (CNS) therapies worldwide
Business Wire
TOKYO & COPENHAGEN, Denmark -- November 21, 2013
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today
announced marketing authorization approval from the European Commission for
Abilify Maintena (aripiprazole), an intramuscular (IM) once-monthly injectable
formulation for maintenance treatment of schizophrenia in adult patients
stabilized with oral aripiprazole.
Abilify Maintena reduces the risk of relapse relative to placebo over the
long-term and provides effective treatment of schizophrenia.^1,2 It has a
tolerability profile similar to oral aripiprazole^1, and demonstrated
statistically significant benefits on patients’ personal and social
functioning as compared to placebo.^1,4 93 percent of patients treated with
Abilify Maintena were extremely, very or somewhat satisfied with their
treatment at the end of the double-blind treatment phase.^4
“We strongly believe the schizophrenia community will welcome the availability
of Abilify Maintena to help improve outcomes for patients living with
schizophrenia. As a company, our focus is to develop treatments to help
protect against relapse and preserve brain function,” said Ole Vahlgren, CEO &
President, Otsuka Europe. “We must partner with health care professionals and
caregivers to help patients get the best treatments that focus on reducing the
risk of relapse.”
“Studies have shown that the early use of long-acting injectables can prevent
a person with schizophrenia from experiencing a relapse,”^5 said Ole Chrintz,
SVP International Markets & Europe, Lundbeck. “Efficacy is important, but a
treatment for a chronic condition such as schizophrenia also needs to be well
tolerated so patients will stay on it over the long-term. We believe Abilify
Maintena meets this need.”^1,2,3
About the Studies
The efficacy of Abilify Maintena was demonstrated in two double-blind, Phase
III, randomized trials. The safety profile for Abilify Maintena was
demonstrated to be similar to that of oral ABILIFY. The most frequently
observed adverse drug reactions (ADRs) reported in ≥5 percent of patients in
two double-blind controlled clinical trials of Abilify Maintena were weight
increases (9.0 percent), akathisia (7.9 percent), insomnia (5.8 percent), and
injection site pain (5.1 percent).^1,2
About Abilify Maintena
Abilify Maintena is the only dopamine D2 partial agonist in once-monthly,
injectable form to receive marketing authorization for maintenance treatment
in schizophrenia. Physicians now have an alternative treatment option, with a
tolerability profile comparable to the well-established oral ABILIFY, to
address the on-going need to reduce the risk of relapse in patients with
schizophrenia.
The European label states that Abilify Maintena is a powder and solvent for
prolonged-release suspension for intra-muscular (IM) injection. It is a
once-monthly formulation of aripiprazole in a sterile lyophilized powder that
is reconstituted with sterile water. Abilify Maintena is indicated for
maintenance treatment of schizophrenia in adult patients stabilized with oral
aripiprazole.
After the first injection, treatment with 10 mg to 20 mg oral aripiprazole
should be continued for 14 consecutive days to maintain therapeutic
aripiprazole concentrations during initiation of therapy.
About Schizophrenia and Disease Relapse
Schizophrenia is a disease characterized by a distortion in the process of
thinking and of emotional responsiveness. It most commonly manifests as
hallucinations, paranoid or bizarre delusions, or disorganized speech and
thinking, and is accompanied by significant social or occupational
dysfunction. Onset of symptoms typically occurs in young adulthood, and the
condition is chronic, often requiring lifelong treatment to mitigate symptoms.
Relapse of schizophrenia refers to an exacerbation or acute psychotic break
that is characterised primarily by the emergence of positive symptoms such as
hallucinations, delusions and disordered thinking.^6
Relapse can occur when a patient no longer responds to antipsychotic
medication, does not take the medication as prescribed, or stops taking their
medication altogether. There are many reasons patients stop taking their
medication, including poor insight about their illness, side effects from
current treatments, complicated medication regimen or lack of support from
family.^7 Abilify Maintena is able to significantly reduce the risk of relapse
in patients with schizophrenia.^1
It has been estimated that schizophrenia affects approximately one percent of
the adult population in the U.S. and Europe, and approximately 24 million
people worldwide.^8,9 In Europe there are approximately 4.4 million adults
with schizophrenia,^10 prevalent equally in both genders.^11,12 While there is
no cure for the disease, symptoms and risk of relapse can be managed in most
patients with appropriate antipsychotic treatment. However, when the disease
is not managed, patients are at increased risk of disease relapse, which can
cause the re-emergence or worsening of psychotic symptoms.^13
Schizophrenia places a significant burden on society. It is regarded among the
most financially costly illnesses and is according to the World Health
Organization (WHO), the 8^th leading cause of DALYs (lost healthy years)
worldwide among patients between the age of 15-44.^11 With 50 percent of
patients not receiving appropriate care and 80 percent of patients relapsing
within the first 5 years,^14 there is a significant unmet need to be addressed
in schizophrenia.
About the Lundbeck and Otsuka Global Alliance
Lundbeck and Otsuka established a global alliance in November 2011 to bring to
bear their considerable experience and resources in the CNS area to introduce
next-generation treatments for conditions such as schizophrenia, depression,
Alzheimer’s disease and alcohol dependency.
About Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the
corporate philosophy: 'Otsuka-people creating new products for better health
worldwide.' Otsuka researches, develops, manufactures and markets innovative
and original products, with a focus on pharmaceutical products for the
treatment of diseases and nutraceutical products for the maintenance of
everyday health.
In pharmaceuticals, Otsuka is a leading firm in the challenging area of mental
health and also has research programs for several under-addressed diseases
including tuberculosis, a significant global public health issue. These
commitments illustrate more powerfully than words how Otsuka is a “big
venture” company at heart, applying a youthful spirit of creativity in
everything it does.
Otsuka is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding
company for the Otsuka Group. The chairman Akihiko Otsuka is the third
generation of Otsuka family members to lead the business, whose origins date
from 1921. The Otsuka Group employs approximately 42,000 people globally and
its products are available in more than 80 countries worldwide. Consolidated
sales were approximately €10 billion or USD 13 billion for fiscal year 2012
(4/1/2012-3/31/2013). Otsuka Pharmaceutical welcomes you to visit its global
website at https://www.otsuka.co.jp/en/
About H. Lundbeck A/S
Lundbeck is a global pharmaceutical company highly committed to improving the
quality of life of people living with brain diseases. For this purpose,
Lundbeck is engaged in the entire value chain throughout research,
development, production, marketing and sales of pharmaceuticals across the
world. The company’s products are targeted at disorders such as depression and
anxiety, psychotic disorders, epilepsy, Huntington’s, Alzheimer’s and
Parkinson’s diseases. Lundbeck’s pipeline consists of several mid- to
late-stage development programmes.
Lundbeck employs more than 5,800 people worldwide, 2,000 of whom are based in
Denmark. We have research in 57 countries and our products are registered in
more than 100 countries. We have research centers in Denmark, China and the
United States and production facilities in Italy, France, Mexico, China and
Denmark. Lundbeck generated revenue of approximately DKK 15 billion in 2012.
For additional information, we encourage you to visit our corporate site
www.lundbeck.com.
REFERENCES:
1. Kane, JM et al. Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week,
multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychiatry 2012;73(5):617-62
Fleischhacker WW, Sanchez R, Perry PP, et al. Aripiprazole once-monthly for the treatment of schizophrenia: a
2. double-blind, randomized, non-inferiority study vs. oral aripiprazole. Annual Meeting of the American Psychiatric
Association, 18–22 May, 2013 (poster).
3. Sanchez R, et al. Patient-reported Outcomes with Aripiprazole-Intramuscular-Depot for Long-term Maintenance
Treatment in Schiziphrenia. NR6-42 2012 (poster)
Carson WH, Perry P, Sanchez R, et al. Effects of a Once-Monthly Formulation of Aripiprazole on Secondary Efficacy
4. Outcomes in Maintenance Treatment of Schizophrenia. Institute on Psychiatric Services meeting, October 4–7, 2012
(Poster)
5. Long-acting injectable antipsychotics in the treatment of schizophrenia: their role in relapse prevention. Agid O,
et al. Expert Opin. Pharmacother. (2010) 11(14):2301-2317
6. Ayuso-Gutierrez JL, del Rio Vega JM. Factors influencing relapse in the long-term course of schizophrenia. Schizophr
Res. 1997; 28(2-3): 199-206
7. Baloush-Kleinman V, et al. Adherence to antipsychotic drug treatment in early-episode schizophrenia: a six-month
naturalistic follow-up study. Schizophr Res. 2011;130(1-3):176-81.
8. National Institute of Mental Health (NIMH). Health Topics: Statistics. Available at
http://www.nimh.nih.gov/statistics/1SCHIZ.shtml. Accessed October 22, 2013
9. World Health Organization (WHO). Schizophrenia Fact Sheet. 2010. Available at:
http://www.who.int/mental_health/management/schizophrenia/en/. Accessed October 22, 2013.
10. World Health Organization (WHO) The global burden of disease:2004 update (2008)
National Institute of Mental Health (NIMH). The Numbers Count: Mental Disorders in America. 2010. Available at
11. http://www.nimh.nih.gov/health/publications/the-numbers-count-mental-disorders-in-America/index.shtml#Schizophrenia.
Accessed October 22, 2013
12. Regier DA, et al. The de facto US mental and addictive disorders service system. Epidemiologic catchment area
prospective 1-year prevalence rates of disorders and services. Arch Gen Psychiatry. 1993;50(2):85-94.
American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia. Second
13. edition. 2004. Available at http://psychiatryonline.org/content.aspx?bookid=28&sectionid=1665359. Accessed October
28, 2013
14. Robinson D, et al. Predictors of relapse following response from a first episode of schizophrenia or schizoaffective
disorder. Arch Gen Psychiatry. 1999;56(3):241-247
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Contact:
H. Lundbeck A/S Contacts
Investors:
Palle Holm Olesen, +45 36 43 24 26
Chief Specialist, Head of Investor Relations
palo@lundbeck.com
Media:
Mads Kronborg, +45 36 43 30 30
Media Relations Manager
mavk@lundbeck.com
or
Otsuka Pharmaceutical Contacts
Media: Europe
Otsuka Pharmaceutical, Europe Ltd.
Alison Ross, +44 7768 337128
aross@otsuka-europe.com
Media: North America
Otsuka America Pharmaceutical, Inc.
Kevin Wiggins, +1 609-524-6879
Kevin.wiggins@otsuka-us.com
Media: Japan /Asia
Otsuka Pharmaceutical Co, Ltd.
Jeffrey Gilbert, +81 3 6361 7379 / +81 80 8728 6039
gilbert.jeffrey@otsuka.co.jp
Investors:
Otsuka Holdings Co., Ltd.
Takuma Kimura, +81 3 6361 7411
Kimurata@Otsuka.jp